As part of the IT Quality team, ensure the delivery of technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Sr. IT Quality Associate II is expected to have working-level knowledge of CS at the enterprise level, including the quality systems supporting the implementation and management of enterprise systems (i.e., change management, exceptions management, risk management). The Sr. IT Quality Associate II is expected to have foundational understanding of regulatory expectations for CS and be able to provide quality oversight and guidance to IT teams to support implementation of and management of enterprise computer systems. This role works with peers locally and globally, to ensure practices are consistent with requirements and expectations set forth within the governing QMS.

What You’ll Do

• Drive the deployment of new GxP computerized systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
• Ensures a state GxP audit readiness through compliant approval of Software Development Life Cycle (SDLC) documentation, validation testing, evaluation of IT Controls procedures, and continuous improvement activities
• Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs.
• Working with senior members of the team, represent ITQ on cross-functional teams in support of SDLC activities for GxP applications – either enterprise platforms or functional specific applications.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems, and IT QMS implementation / remediation.

Who You Are

You are an experienced member of a QA organization with a BA/BS in Engineering or Life Sciences and a minimum of 5+ years related QA experience and/or training with 5 years in a CSV / Quality role. You are passionate about compliance, have a keen eye for detail and are a strong communicator.

Required Skills

• BA/BS in Engineering or Life Sciences and a minimum of 5+ years related QA experience and/or training with 5+ years in a CSV / Quality role.
• Understanding of key compliance components as it relates to computer systems validation
• Ability to complete complex tasks independently
• Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation
• Knowledge of respective regulations governing computer systems and controls such as 21 CFR Part 11, Annex 11, MHRA’s data integrity guidance, etc.
• Understanding of risk-based methodologies as it relates to CSV and general Quality practices

Preferred Skills

• Experience supporting global regulatory inspections (FDA, MHRA, ANVISA, etc.) a plus
• Background in Lifesciences and/or Pharma/Biotech industries

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.